Work as MQ TS Downstream Supervisor at Pfizer

Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Post : MQ TS Downstream Supervisor

Job Description :
The MQ TS Downstream Supervisor is responsible for ensuring Sterilization, Visual inspection & Packing area are operating under a State of cGMP Compliance. The Supervisor is directly responsible for managing and coordinating all quality functions within the area. This individual must also work with Cross functional teams. Other Certifications: Trained in investigation and tools used for investigation. Yellow Belt/Green Belt/PHP/Any other certifications relevant for the role.

Technical Skills:
• Advanced/well developed skills and knowledge of terminal sterilization process/ Visual Inspection/Packaging.
• Should be capable of handling regulatory inspections USFDA/MHRA/TGA, etc
• Knowledge of various Quality tools required for investigations
Technical Writing- Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed to be understood by any level of organization.

Responsibilities:
• Responsible for leading a team of qualified MQA Specialists and Sr. Specialists in respective shift.
• Manages own time to meet objectives, forecasts and plans resource requirements (people, financial and technology) for projects across department.
• Develops goals and objectives for the quality assurance team to obtain maximum efficacy from department including delivery of cost saving initiatives.
• Responsible for ensuring operating state of cGMP compliance in Manufacturing, Terminal Sterilization, Visual Inspection and Packaging operations.
• Manage and coordinate all quality functions through Pfizer Quality Systems.
• Thorough knowledge of Terminal Sterilization, Visual Inspection and Packing.
• Ensure manufacturing policies, procedures and standards confirm to pre-defined regulatory / site standards / specifications and corporate standards.
• Responsible for assisting manufacturing investigators in conducting investigations, leading manufacturing investigations and implementation of CAPAs.
• Manage investigations and apply relevant and necessary actions/systems to ensure appropriate levels of compliance.
• Should have leadership qualities with trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
• Provides guidance to and may lead moderate to complex projects
• To identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime and increase the Efficiency.
• Experience in handling regulatory, corporate and internal auditors/ inspectors.

Candidate Profile
M.Phram / B.Pharm / M.Sc (Any Specialization)
Preferably 10 - 15 years of experience in Manufacturing Quality / Production or in Quality Assurance of a pharmaceutical manufacturing facility.

Additional Information
Qualification : M.Pharm, M.Sc, B.Pharm
Experience : 10-15 years
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : MQ TS Downstream
End Date : 15th October, 2018